APPASOL - 5

(Sodium Chloride Ophthalmic Solution USP)

THIS LEAFLET CONTAINS IMPORTANT PRODUCT USE AND SAFETY INFORMATION, PLEASE READ CAREFULLYAND RETAIN FOR FURTHER REFERENCE.

DESCRIPTION:

APPASOL-5 Eye Drops(Sodium Chloride Ophthalmic Solution USP 5% w/v) is a sterile, nonpyrogenic, hypertonic solution. The pH may have been adjusted with hydrochloric acid or NaoH.

COMPOSITION:

Each ML Contains:

• Sodium Chloride USP                 5% w/v
  Preservative:-
• Methylparaben USP                  0.023%w/v
• PropylparabenUSP                  0.01% w/v
• Aqueous Buffered Vehicle               q.s.

INDICATION AND USAGE

APPASOL-5 Eye Drops (Sodium Chloride Ophthalmic Solution USP 5% w/v) is used to reduce swelling of the surface of the eye (cornea) in certain eye conditions. Decreasing swelling of the cornea may lessen eye discomfort or irritation caused by the swelling. This product works by drawing fluid out of the cornea to reduce swelling.

DOSAGEAND ADMINISTRATION

Instill one to two drops in the affected eye(s) every 3 to 4 hours, or as directed by the doctor.

PHARMACOLOGICAL PROPERTIES :

Sodium Chloride in APPASOL-5 Eye Drops is used as an iso- osmotic agent, which contains a buffer and may contain suitable anti-microbial and stabilizing agents. Sodium Chloride is the principal salt involved in maintaining the osmotic tension of the blood and tissues; changes in osmotic tension influence the movement of fluids and diffusion of salts in cellular tissues. Solutions containing sodium chloride are extensively used for the prevention or correction of fluid and electrolyte deficits or imbalance in a wide range of clinical situations. Oral administration may be effective but usually such solutions must be given intravenously. Isotonic or hypotonic (0.18 and0.45%) sodium chloride solutions may be given in certain circumstances for fluid replacement and hypernatraemia. Sodium Chloride 0.9% being isotonic, is a useful fluid for sterile irrigations and wound cleansing.

Pharmacokinetics                                                                        

Sodium Chloride is well absorbed from the gastrointestinal tract. Sodium is predominantly excreted by the kidney, but there is extensive renal reabsorption. Small amount of sodium are lost in faeces and sweat.

CONTRAINDICATION:

None known

WARNINGS AND PRECAUTIONS:

Do not use
‍- Except under theadvice and supervision of a doctor
- if solution changescolor or becomes cloudy

‍When using this product 
- It may cause temporaryburning and irritation
-To avoid contamination do not touch tip of container to any surface
- Replace cap after use 

‍Stop use and ask a doctor if
‍- condition worsens or persists for more than 72 hours you experience eye pain, changes in vision, continued redness or irritation of the eye If swallowed, get medical help or contact a Poison Control Center right away.

UNDESIRABLE EFFECTS:

The product may cause temporary burning and irritation on being applied into the eye. If pain, changes in vision, continued redness or irritation of the eye is experienced, or if the condition worsens or persists, consult an ophthalmologist

STORAGE

Preserve in tight containers, at a temperature not exceeding 30°C. Do not allow to Freeze.

SHELF LIFE:

24 Months

HOW SUPPLIED:

APPASOL-5 Eye Drops / 10 mL (Sodium Chloride Ophthalmic Solution USP 5% w/v) is supplied in 10 mL poly bottle